Engineer, GxP Systems
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Support Engineer, GxP is responsible for the technical design, planning, implementation, and support of enterprise systems and laboratory equipment to ensure that these are operating at optimum levels. You will serve as the technical expert in systems administration for specialized manufacturing, development, and quality control systems and recommend the redesign, configuration, recovery, and continuity plans of the operational and information technology and applications for these systems. You will analyze the feasibility of system requirements and develop system specifications and will support project leadership and management in the identification, development, and adoption of technology and processes to deliver quality reliable solutions in the support of our core manufacturing and quality control operations.
- Maintain system administration documentation for various laboratory instruments, enterprise systems, and manufacturing equipment.
- Support the generation and/or modification of test methods for various laboratory equipment.
- Provide technical and documentation support for the change management process on the supported systems and equipment.
- Perform equipment testing as needed. Trais technical staff in the operation of developed and/or acquired software and hardware.
- Provide tools, procedures, and training sessions for Operations, Support and Systems Development staff who assist in support efforts.
- Provide guidance or work instructions to internal and external users.
- Perform troubleshooting and support problem-solving efforts with vendors.
- Support security policies and procedures to protect systems from unauthorized or unintended use and/or abuse.
- Coordinate and support project efforts to maximize benefits and minimize impact to departments and operations.
- Other tasks as assigned.
Minimum Qualifications:
- Bachelor's degree in Life Sciences, Computer Science, or related disciplines. Relevant experience may substitute for the degree requirement on a year for year basis.
- 1+ years' work experience in technical writing, complex systems design, and support.
- Experience using a combination of the following software: Spectramax Softmax Pro, HPLCS, BioTek plate readers, Beckman 32Karat, Empower 3, EndoscanV, Applied Biosystems, Beckman Vi-Cell BLU, Sartorius Sartochecks, iCE Protein Simple, Sievers TOC, Cary SoloVPE, Cytiva Unicorn, Thermo DeltaV, Sartorius MFCS, Bio-Rad Image Lab Densitometer, Acronis, Veeam, Beckman Spectraphotometer.
- Ability to establish and maintain cooperation, understanding, trust, and credibility.
- Ability to plan, organize, and document complex system design activities and to configure systems to be consistent with organization's policies/procedures
- Ability to communicate technical/complex information verbally and in writing.
- Ability to perform tasks timely and efficiently and respond to emergency situations effectively as needed.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours if needed. This position includes participation in an on-call rotation to provide support outside of regular business hours.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $72,000 to $90,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.